Effects of a Probiotics on the Health of Normal Young Males (FFF)

Vaud University Hospital Center

Status: Completed

Conditions: Inflammation; Dyslipidemia

Treatments: Dietary Supplement: Acidified milk; Dietary Supplement: Probiotic yogurt

Study type: Interventional

Funder types: Other

Identifiers

NCT02230345

392/13

Details and patient eligibility

About

The important role played by the GI tract microflora on the metabolic health of an individual are increasingly recognized. In this respect, the initial studies of Metchinkoff that suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora have evolved into the concept of "probiotics". Probiotics are living microorganisms that bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).

Here the investigators will study, in normal young male volunteers, the potential to modulate post-prandial metabolic and inflammatory responses by the administration of a yoghourt containing the probiotic Lactobacillus rhamnosus (LGG).

Full description

This is a prospective, randomized, double-blind and cross-over study designed to evaluate the potential of a probiotic (Lactobacillus rhamnosus) to modulate the post prandial metabolic and inflammatory response of normale healthy individuals.

After a wash out period during which volunteers will have to follow a diet devoid of all milk or milk-derived products, they will receive, in random order, either a daily dose of the probiotic, or a daily dose of acidified milk (control) for a total of three consecutive weeks. At the end of each of these period, they will be submitted to a day of investigation, during which their metabolic and inflammatory profile will be studied following the ingestion of a standard test meal. The potential for the probiotic to modulate the metabolic and inflammatory parameters will be evaluated.

The test meal will provide 1004Kcal under the form of 45.4g proteins (17%), 69g total fatty acids (62%), and 52.6g glucids (21%) as previously published (Schwander et al, J Nut 2014).

Enrollment: 14 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal male with normal BMI (18.5-25 kg/m2)
• non smoker
• stable physical activity

Exclusion criteria

• Food intolerance (ceoliac disease, lactose intolerance, food allergies)
• Particular regimen (vegetarian...)
• Chronic disease (any)
• Elevated blood pressure
• Regular drug treatment
• Antibiotics treatement in the preceding six months
• >4 hrs/week of physical activity

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups

Probiotic yogurt

Experimental group

Description:

Daily administration, during two weeks, of two probiotic yogurts (200 mL each)

Treatment:

Dietary Supplement: Probiotic yogurt

Acidified milk

Active Comparator group

Description:

Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk

Treatment:

Dietary Supplement: Acidified milk